Apparatuses and method for injecting medicaments

ABSTRACT

An injector for delivering medicament includes a first sleeve defining a longitudinal axis, a medicament container, and a locking tab. The medicament container is at least partially disposed within the first sleeve and configured for axial translation with respect to the first sleeve along the longitudinal axis. The medicament container includes a barrel, a needle mounted to a distal end of the barrel, a seal slidably mounted in the barrel, and a plunger rod. The locking tab extends through an aperture in the first sleeve and is in contact with or adjacent to a portion of the medicament container such that the locking tab restricts translation of the barrel with respect to the first sleeve along the longitudinal axis. The locking tab is configured to be movable to a second position in which the locking tab does not restrict translation of the barrel.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.62/696,144, filed on Jul. 10, 2018, the entirety of which isincorporated herein by reference.

FIELD

The invention relates to injectors for medicaments. Specifically, toinjectors configured to inject a medicament from a syringe.

BACKGROUND

Many methods are used to inject medicaments into a target site. Theseinclude syringes, auto-injectors, and drug pumps. The medicament can beinjected at a variety of depths. For example, the medicament can beinjected into the epidermis, the dermis, the subcutaneous region, orinto the muscles (intramuscular). Some of these devices are specificallyintended for at home use by a patient. These devices can be used todeliver a variety of medicaments. For example, the injectors can be usedfor the delivery of epinephrine to patients who are at risk ofanaphylaxis. Such devices include the ANAPEN™ injector sold by LincolnMedical Ltd. of the United Kingdom and the EPIPEN® injector sold byMylan Inc. of Pennsylvania.

Many injectors use powerful springs to drive a plunger rod into apre-filled syringe and inject the medicament into the tissue whilepushing the injector into the side of the leg or other body location.Some of these injectors have the advantage of shielding the needlebefore and/or after use, thereby benefiting patients who have a fear ofneedles. Present injectors can contain more than twenty-six parts and becomplicated to assemble due to the amount and complexity of the parts,which results in high prices to the user. The additional parts alsoincrease the chance of failure of these complex devices.

In some applications, such as, for example, biologics, medicament isprovided in a lyophilized form and is mixed with a diluent prior toinjection to reconstitute the medicament. In such applications, themedicament may be provided in a vial or in a dual-chamber syringe orcartridge. Storage in the lyophilized form may increase the shelf lifeand/or efficacy of the medicament. However, the need to mix themedicament with the diluent introduces further steps and complicationsfor the user and increases the risk of user error.

SUMMARY

In one aspect, an injector for delivering medicament includes a firstsleeve defining a longitudinal axis, a medicament container, and alocking tab. The medicament container is at least partially disposedwithin the first sleeve and configured for axial translation withrespect to the first sleeve along the longitudinal axis. The medicamentcontainer includes a barrel, a needle mounted to a distal end of thebarrel, a seal slidably mounted in the barrel, and a plunger rod. Thelocking tab extends through an aperture in the first sleeve and is incontact with or adjacent to a portion of the medicament container suchthat the locking tab restricts translation of the barrel with respect tothe first sleeve along the longitudinal axis. The locking tab isconfigured to be movable to a second position in which the locking tabdoes not restrict translation of the barrel.

In another aspect, an injector for delivering medicament includes afirst sleeve defining a longitudinal axis, a second sleeve, a medicamentcontainer, a locking tab, and a pull tab. The second sleeve extends fromthe first sleeve such that the second sleeve is configured to translatewith respect to the first sleeve along the longitudinal axis. Themedicament container is at least partially disposed within the firstsleeve and is configured for axial translation with respect to the firstsleeve along the longitudinal axis. The medicament container includes abarrel, a needle mounted to a distal end of the barrel, a seal slidablymounted in the barrel, and a plunger rod. The locking tab restrictstranslation of the barrel with respect to the first sleeve along thelongitudinal axis. The pull tab covers a distal aperture of the secondsleeve. The locking tab is coupled to the pull tab such that the lockingtab is removable using the pull tab.

In another aspect, a method of injecting medicament includes providingan injector. The injector includes a first sleeve defining alongitudinal axis, a medicament container, and a locking tab. Themedicament container is at least partially disposed within the firstsleeve and is configured for axial translation with respect to the firstsleeve along the longitudinal axis. The medicament container includes abarrel, a needle mounted to a distal end of the barrel, a seal slidablymounted in the barrel, and a plunger rod. The locking tab restrictstranslation of the barrel with respect to the first sleeve. The methodfurther includes depressing the plunger rod of the medicament containerto mix a diluent with a lyophilized substance within the barrel of themedicament container. The method further includes disengaging thelocking tab from the medicament container. The method further includesplacing a distal end of the injector against a target site. The methodfurther includes depressing the plunger rod to deliver the mixed diluentand lyophilized substance.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features of the devices and methods provided herein willbe more fully disclosed in, or rendered obvious by, the followingdetailed description of the preferred embodiment of the invention, whichis to be considered together with the accompanying drawings wherein likenumbers refer to like parts and further wherein:

FIG. 1 is an isometric view of one embodiment of an injector for amedicament;

FIG. 1A is a cross-sectional view of the injector of FIG. 1;

FIG. 1B is an isometric view of the embodiment of FIG. 1 with the capremoved;

FIG. 2 is an exploded view of the injector of FIG. 1;

FIG. 2A is a cross-sectional view of a cap;

FIG. 3 is an isometric view of an outer sleeve;

FIG. 4 is an isometric view of an inner sleeve;

FIG. 5A is a cross-sectional view of the injector of FIG. 1 in aninitial configuration;

FIG. 5B is a detail view of the flex arm and raised curb in the initialconfiguration;

FIG. 6A is a cross-sectional view of the injector of FIG. 1 in a secondconfiguration;

FIG. 6B is an isometric view of the injector of FIG. 1 in the secondconfiguration;

FIG. 6C is a detail view of the flex arm and raised curb in the secondconfiguration;

FIG. 7A is a cross-sectional view of the injector of FIG. 1 in a thirdconfiguration;

FIG. 7B is an isometric view of the injector of FIG. 1 in the thirdconfiguration;

FIG. 7C is a detail view of the flex arm and raised curb just prior tocompletion of the delivery of the medicament;

FIG. 7D is a detail view of the flex arm and raised curb just aftercompletion of the delivery of medicament;

FIG. 8A is a cross-sectional view of the injector of FIG. 1 in a fourthconfiguration;

FIG. 8B is an isometric view of the injector of FIG. 1 in the fourthconfiguration;

FIG. 8C is a detail view of the flex arm and raised curb in the fourthconfiguration

FIG. 9 is an isometric view of another embodiment of an injector;

FIG. 10 is an exploded view of the injector of FIG. 9;

FIG. 11 is an isometric view of the injector of FIG. 9 prior to assemblyof the cap onto the injector;

FIG. 12 is an isomeric view of the injector of FIG. 9 after removal ofthe cap and needle cover from the injector;

FIG. 13 is an isometric view of the injector of FIG. 9 after use;

FIG. 14A is an isometric view of an injector and a spray nozzle;

FIG. 14B is a side view of the injector and spray nozzle of FIG. 14A inan assembled configuration;

FIG. 14C is an isometric view of the injector and spray nozzle of FIG.14A during use;

FIG. 14D is a cross-sectional view of the injector and spray nozzle ofFIG. 14A in a first configuration;

FIG. 14E is a cross-sectional view of the injector and spray nozzle ofFIG. 14A in a second configuration;

FIG. 15 is an isometric view of an injector having a luer connector anda tubing set;

FIG. 16 is an isometric view of an injector having a grip;

FIGS. 17A-17H are cross-sectional views of a reconstitution injector atvarious stages of operation;

FIG. 18 is an end view of the reconstitution injector of FIGS. 17A-17H;

FIG. 19A is a top view of a pull tab and locking tab according to oneembodiment described herein;

FIG. 19B is a side view of the pull tab and locking tab of FIG. 19A;

FIG. 20 is a detail view of the locking tab of FIG. 19A engaged with thebarrel of the medicament container to prevent translation of the barrel;

FIG. 21 is a detail view of the second seal of the medicament containeraligned with the bypass channel of the barrel;

FIG. 22 is a detail view of the proximal end of the reconstitutioninjector of FIGS. 17A-17H; and

FIG. 23 is a side view of the reconstitution injector of FIGS. 17A-17H.

DETAILED DESCRIPTION

This description of preferred embodiments is intended to be read inconnection with the accompanying drawings, which are to be consideredpart of the entire written description of this invention. The drawingfigures are not necessarily to scale and certain features of theinvention may be shown exaggerated in scale or in somewhat schematicform in the interest of clarity and conciseness. In the description,relative terms such as “horizontal,” “vertical,” “up,” “down,” “top,”and “bottom” as well as derivatives thereof (e.g., “horizontally,”“downwardly,” “upwardly,” etc.) should be construed to refer to theorientation as then described or as shown in the drawing figure underdiscussion. These relative terms are for convenience of description andnormally are not intended to require a particular orientation. Termsincluding “inwardly” versus “outwardly,” “longitudinal” versus “lateral”and the like are to be interpreted relative to one another or relativeto an axis of elongation, or an axis or center of rotation, asappropriate. Terms concerning attachments, coupling and the like, suchas “connected” and “interconnected,” refer to a relationship whereinstructures are secured or attached to one another either directly orindirectly through intervening structures, as well as both movable orrigid attachments or relationships, unless expressly describedotherwise. The term “operatively or operably connected” is such anattachment, coupling or connection that allows the pertinent structuresto operate as intended by virtue of that relationship. In the claims,means-plus-function clauses, if used, are intended to cover thestructures described, suggested, or rendered obvious by the writtendescription or drawings for performing the recited function, includingnot only structural equivalents but also equivalent structures. Theterms “medicament” or “drug” as used herein refers to any substance fordelivery to a target. For example, these terms include anticoagulants,vaccines, biologics, and any injectable fluid.

The present disclosure provides an injector for injecting medicamentinto a target site. The injector provides for easy use by a patient orother caregiver and is configured for reliable use after being storedfor long periods of time. In addition, because the injector utilizes alow number of parts, it is inexpensive and easy to manufacture. Theinjectors described herein can be used to deliver, for example,biologics, epinephrine, ketamine, moxifloxacin, ertapenem, atropine,diazepam, or naloxone.

FIG. 1 shows an isometric view of an injector 100 in an as-shippedconfiguration. The injector 100 includes a body 102, and a cap 103. Withthe cap 103 engaged with the body 102, it is not possible to operate theinjector 100 to distribute the contents of the injector 100. Theinjector can also include a label 101. The label 101 can wrap aroundboth the body 102 and at least a portion of the cap 103 to preventinadvertent removal of the cap 103. In addition, this arrangement of thebody 102, cap 103, and label 101 can maintain the sterility of thesyringe contained within the injector 100. The label can include aperforated portion 101 a which allows for the tearing of the label 101and removal of the cap 103. The perforation can be positioned atapproximately the proximal end of the cap 103, thereby allowing for thetearing of the label 101 and removal of the cap 103. The label 101 canbe torn at the perforations by, for example, rotation of the cap 103with respect to the body 102, as shown in FIG. 1B. In some embodiments,the perforations do not pass fully through the label 101 (i.e., theperforations only partially pass through the label). In such embodiment,by enveloping the body 102 and the cap 103 with the label 101, theinflow of materials to the injector 100 is restricted. For example, thelabel 101 may provide water resistance which prevents water fromentering the injector. This advantageously protects the contents of theinjector 100.

As can be seen in the exploded view of FIG. 2, the body 102 includes anouter sleeve 104 and an inner sleeve 106. A syringe 108 is disposedwithin the body 102. The outer sleeve 104 defines a longitudinal axis A.After assembly, the inner sleeve 106 is disposed partially within theouter sleeve 104. The outer sleeve 104 and the inner sleeve 106 are, inthe illustrated embodiment, generally cylindrical in shape. However, theouter sleeve 104 and inner sleeve 106 can be of any appropriate shape,with the shape being chosen to provide the desired external appearance.

The syringe 108 is pre-filled with a medicament and includes a barrel110, a needle 112 (shown in FIG. 5A), a needle cover 113, a seal 114,and a plunger rod 116. The syringe 108 is pre-filled with a medicament.The barrel 110 can be a glass barrel, such as those constructed fromstraight cane glass. Alternatively, the barrel 110 can be constructed ofa polymeric material. The barrel 110 can be coated with a material toreduce chemical interactions between the barrel 110 and the medicament.The needle 112 is mounted at the distal end of the barrel 110 anddefines a lumen through which medicament can be delivered from thebarrel 110 to the target site. The needle 112 can be attached to thebarrel 110 using any appropriate method, such as staking and adhesives.The seal 114 is disposed within the barrel 110 and is configured foraxial translation within the barrel 110. The seal 114 can be constructedof an elastomeric material and provide a seal against the inner wall ofthe barrel 110 to maintain the sterility of the medicament prior to use.The plunger rod 116 is engaged with the seal and includes an elongatedportion which extends from the proximal end of the barrel 110 and a cap116 a.

In the as-shipped configuration, as shown in FIG. 1A, the cap 103engages the needle cover 113. Hence, removal of the cap 103 from thebody removes the needle cover 113 from the syringe. As shown in FIG. 2A,the cap 103 includes projections 103 a which engage the distal end ofthe needle cover 113. The needle cover 113 can include a flange 113 aadjacent its distal end. The projections 103 a can include teeth 103 bwhich are configured to engage the flange 113 a. As such, when the cap103 is removed, the needle cover 113 is removed as well. The projections103 a pass through an aperture at the distal end of the inner sleeve 106to provide access to the needle cover 113.

Rotation of the cap 103 with respect to the body 102 during removal canalso cause rotation of the needle cover 113 with respect to the syringe108. This rotation can assist in overcoming any sticking of the needlecover 113 to the syringe 108, thereby making removal of the cap 103 andneedle cover 113 easier for the user.

The injector 100 can also include a biasing member 117. The biasingmember can be disposed at least partially proximally to the inner sleeve106 and bias the inner sleeve 106 to an extended position, as shown inFIG. 5A. The distal end of the biasing member 117 can be in contact withthe inner sleeve 106, while the proximal end of the biasing member 117can be in contact with the plunger rod 116 or the outer sleeve 104. Thebiasing member 117 can be any appropriate member capable of storing andreleasing energy. For example, the biasing member 117 can be aspring—such as a coil spring or a helical spring, an elastomeric sleeve,or a flexible arm extending from the outer sleeve 104. As will bedescribed further herein, the biasing member 117 maintains the innersleeve 106 in the extended position prior to insertion of the needleinto the target and also causes the inner sleeve 106 to extend afterremoval of the injector 100 from the target location. The stiffness ofthe biasing member 117 can be significantly lower than that used inother injectors. For example, in one embodiment, the biasing member 117is a compression spring with a spring rate between approximately 0.50lbs./in. and 0.60 lbs./in. In another embodiment, the spring rate isbetween approximately 0.25 lbs./in. and 0.75 lbs./in. In anotherembodiment, the spring rate is between approximately 0.10 lbs./in. and0.50 lbs./in. The use of a biasing member with lower stiffness thanother injectors, the cost of the biasing member itself is reduced. Inaddition, the cost of other parts of the injector can be lower becausethey do not need to be configured to withstand the higher forces.

As shown in FIG. 3, the outer sleeve 104 has a generally cylindricallyshaped sidewall 118 defining a proximal end 120 and a distal end 122. Asshown, the outer sleeve can be constructed in a clamshell typearrangement with a first portion 121 connected to a second portion 123by a living hinge. During assembly, the first portion 121 and secondportion 123 are brought together to fixedly close the outer sleeve 104.Alternatively, the first portion 121 and second portion 123 can beseparate components (i.e., not connected by a living hinge). In such anembodiment, the separate first portion 121 and second portion 123 arebrought together during assembly. The outer sleeve 104 can includefeatures to retain the first portion 121 and second portion 123 in afixed relationship for storage and use. For example, one of the firstportion 121 or the second portion 123 can have flex arms configured toengage recesses or cavities on the opposite portion. Alternatively, thefirst portion 121 and second portion 123 can be connected using a heatstaking process, wherein a stud on one of the first portion 121 andsecond portion 123 is expanded using heat to fill a hole of the oppositeportion. Alternatively, the first portion 121 and the second portion 123can be welded to one another using ultrasonic welding or anotherprocess.

Also during assembly, the plunger rod 116 is engaged with the outersleeve 104, for example at the proximal end 120. As such, the plungerrod 116 and the outer sleeve 104 are in a fixed spatial relationshipsuch that the plunger rod 116 and the outer sleeve 104 translate as aunit throughout operation of the injector 100. In one embodiment, thesidewall 118 defines a keyway 124 and the plunger rod 116 includes acorresponding key 125. During assembly, the key 125 is disposed in thekeyway 124 to prevent relative movement between the plunger rod 116 andouter sleeve 104. Alternatively, the plunger rod 116 can be engaged withthe outer sleeve 104 using any appropriate method, including a press fitinterface, bonding of the plunger rod to the outer sleeve, a screwthread engagement, or a pin connecting the plunger rod to the outersleeve.

The outer sleeve 104 also includes a raised curb 126, as shown best inFIG. 3. The raised curb 126 extends from the sidewall 118. The raisedcurb 126 extends along a path which has a longitudinal component,parallel to longitudinal axis A, and a circumferential componentextending along the circumference of the outer sleeve 104. In someembodiments, the raised curb 126 is disposed within a recess 128 in thesidewall 118. The recess 128 allows the raised curb 126 to interfacewith the inner sleeve 106 without imparting an inward radial force onthe inner sleeve 106. Additionally, the recess 128 defines a strike face129 at the proximal end of the raised curb 126. In at least oneembodiment, the outer sleeve 104 includes at least two raised curbs 126.In the illustrated embodiment, the outer sleeve includes two raisedcurbs 126 which are positioned 180° from each other (directly oppositeone another). This creates balanced forces on the inner and outersleeves.

The inner sleeve 106 can also be provided in a clamshell configurationas described above with reference to the outer sleeve 104. As shown inFIG. 4, the inner sleeve 106 includes a sidewall 130 defining a proximalend 132 and a distal end 134. As described above, the biasing member 117can be in contact with the proximal end 132 to bias the inner sleeve 106to an extended position. The inner sleeve 106 also includes one or moreengagement members 135 that extend into a chamber defined within thesidewall 130 between the proximal end 132 and the distal end 134. Aswill be described in more detail below, the engagement members 135 areconfigured to contact the syringe 108 during operation to limit thedepth of insertion of the needle 112 into the target location. In theembodiment shown, the engagement members 135 are spaced apart from thedistal end 134. The distance that the engagement members 135 are spacedapart from the distal end 134 defines the depth of insertion of theneedle 112. Hence, the depth of insertion can be accurately controlledduring the manufacturing of the inner sleeve 106. Appropriate tolerancescan be applied to the distance between the engagement members 135 andthe distal end 134 of the inner sleeve 106 to ensure that the injectionreaches the desired position in the tissue. For example, in oneembodiment, the needle 112 extends approximately 16 mm (0.62 inches)from the distal end of the inner sleeve 106. In another embodiment, theneedle 112 extends approximately 25 mm (1.0 inch) from the distal end ofthe inner sleeve 106. In another embodiment, the needle 112 extendsapproximately 38 mm (1.5 inches) from the distal end of the inner sleeve106. The engagement members 135 can be integrally formed with the innersleeve 106 or, alternatively, can be separate components that areassembled to the inner sleeve 106.

As shown in FIG. 4, the inner sleeve 106 also includes a flex arm 136.The flex arm 136 generally extends parallel to the longitudinal axis Aand includes a protrusion 138 extending radially outward, toward theouter sleeve 104. The protrusion 138 interfaces with the raised curb 126during the operation of the injector 100, as will be described furtherbelow. In the illustrated embodiment, the inner sleeve 106 includes twoflex arms 136 which are positioned 180° from each other (directlyopposite one another). As described above, this ensures that the forcesapplied to the inner sleeve 106 are balanced.

FIGS. 5A-8C show views of the steps of operation of the injector 100.Prior to use, the cap 103 is removed from the injector 100. Because thecap 103 is engaged with the needle cover 113, removal of the cap 103removes the needle cover 113 from the syringe 108. The cap and needlecover can now be discarded. Subsequently, as shown in FIG. 5A, thedistal end 134 of the inner sleeve 106 is placed against the targetlocation. As seen in FIG. 5A, in this configuration, the inner sleeve106 extends from the outer sleeve 104 a first distance and covers theneedle 112. Additionally, in this configuration, the biasing member 117is in a relatively de-energized state. In this de-energized state, thebiasing member 117 is not applying significant forces to the componentsof the injector 100. This allows the injector 100 to be stored forextended periods of time without risk of damage to the componentstherein.

As shown in FIG. 5B, in this initial configuration, the protrusion 138of the flex arm 136 is initially positioned at the distal end of theraised curb 126. The protrusion is positioned on the first side of theraised curb 126. In this configuration, the flex arm 136 is in anunstressed state (i.e., the interaction of the protrusion 138 with theraised curb 126 does not cause deflection of the flex arm in thisconfiguration). This ensures that these parts do not creep, or take on apermanent deformation, during storage. This allows the device to bestored for extended periods without risk of damaging the components,thereby increasing the reliability of the injector.

As shown in FIG. 6A, force applied to the outer sleeve in the distaldirection causes the outer sleeve 104 to move toward the target locationand, hence, causes the extension of the inner sleeve from the outersleeve to be reduced to a second distance. This can also be seen in theisometric view of FIG. 6B. Because the plunger rod 116 is engaged withthe outer sleeve 104, the plunger rod 116 translates with the outersleeve 104. The plunger rod 116 causes movement of the seal 114 and,because the seal 114 is in sealing engagement with the barrel 110,static frictional forces between the seal 114 and the barrel 110 causemovement of the syringe 108. The syringe 108 translates, with the outersleeve 104, in the distal direction until the syringe 108 comes incontact with the engagement members 135. This translation of the syringe108 causes the needle 112 to be inserted into the target location. Theengagement members 135 can contact the barrel 110 of the syringe or acrimp cap or other component engaged with the barrel 110. At this point,shown in FIGS. 6A and 6B, continued translation of the syringe barrel110 is restricted.

Translation from the configuration shown in FIG. 5A to that shown inFIG. 6A causes the biasing member to be compressed or energized, therebystoring energy for later release.

As shown in FIG. 6C, as the outer sleeve 104 translates with respect tothe inner sleeve 106 from the first configuration to the secondconfiguration, the protrusion 138 of the flex arm 136 travels along thefirst side 126 a of the raised curb 126. As it does so, the flex arm 136is deflected from its unstressed, natural position to the deflectedposition shown in FIG. 6C.

Continued displacement of the outer sleeve 104 causes injection of themedicament, as shown in FIG. 7A. As shown in FIGS. 7A and 7B, theextension of the inner sleeve 106 from the outer sleeve 104 is furtherreduced. Because the syringe barrel 110 is restricted from furthermovement by contact with the engagement members 135, continueddisplacement of the outer sleeve 104 and plunger rod 116, causes theseal 114 to translate within the barrel 110 of the syringe 108. Thiscauses the medicament to be expelled from the barrel 110, through theneedle 112, and into the target. Additionally, the biasing member 117 isfurther compressed or energized.

As shown in FIG. 7C, this continued translation of the outer sleeve 104causes the protrusion 138 to reach the proximal end of the raised curb.As shown in the transition from FIG. 7C to FIG. 7D, at completion ofexpulsion of the medicament, the protrusion 138 disengages from thefirst side 126 a of the raised curb 126. As the protrusion disengages,the elastic energy stored in the flex arm 136 causes the flex arm 136 toreturn toward its natural position. As it does so, the protrusion 138 oranother portion of the flex arm 136 contacts the strike face 129 on theouter sleeve 104. The contact with the strike face 129 provides audibleand/or tactile feedback to the user that delivery of the medicament iscomplete.

The volume of medicament that the injector 100 is configured to injectmay be controlled during manufacturing by varying the length of theraised curb 126. For example, shortening the raised curb 126 reduces thevolume of medicament that will be injected by the injector 100.Conversely, lengthening the raised curb 126 increases the volume ofmedicament that the injector 100 will inject. In embodiments in whichthe outer sleeve 106 is manufactured by an injection molding process,the mold for the outer sleeve 106 may be configured such that the raisedcurb 126 is formed, at least in part, using a mold insert. In suchembodiments, the length of the raised curb 126 may be varied by usingdifferent mold inserts. This may reduce the tooling and manufacturingcosts of the injector 100.

As shown in FIGS. 8A-8C, after completion of the injection, and removalof the injector 100 from the target, the biasing member 117 de-energizesand causes the inner sleeve 106 to translate in the distal directionwith respect to the outer sleeve 104, such that the inner sleeve 106extends a third distance from the outer sleeve 104. The third distancecan be the same as the first distance or, alternatively, can bedifferent. As the inner sleeve 106 extends, it covers the needle 112.Hence, the needle 112 is covered both before and after use of theinjector 100. This protects against needle-stick injuries and hides theneedle from sight, which is particularly important for patients with afear of needles.

While the inner sleeve 106 extends, the protrusion 138 travels along thesecond side 126 b of the raised curb 126. Upon full extension of theinner sleeve 106, the protrusion 138 snaps into the cavity 127 formedbetween the proximal end of the raised curb 126 and a locking member139. In this position, the protrusion prevents translation of the innersleeve 106 in either the proximal or distal directions. Hence, the innersleeve is locked in position and cannot be translated to expose theneedle 112. In at least one embodiment, the flex arm 136 is in astressed or deformed position when the protrusion is disposed in thecavity 127. As a result, the internal forces in the flex arm 136 pushthe protrusion 138 into the end of the raised curb 126 to furtherprevent retraction of the inner sleeve 106.

In one embodiment, the protrusion 138 has an “L” shaped cross-section.As a result, a notch is formed that engages the end of the raised curb126 to lock the flex arm 136 in position.

In other embodiments, as shown in FIGS. 9-13, a syringe with aretractable needle is used. Repetitive description is not includedherein, however, such an embodiment can include many of the samefeatures, aspects, and configurations as those described above withrespect to the embodiment of FIGS. 1-8C. In such an embodiment, theneedle of the syringe is configured to retract into the barrel of thesyringe after completion of the injection. One example of such a syringeis the BD INTEGRA® syringe sold by Becton Dickinson of New Jersey.However, any retractable needle syringe can be used. The syringe caneither be pre-filled or, alternatively, filled at time of use by drawingmedicament from a vial. In the case of a fill at time of use, a vialadapter can be used.

The injector 200 of FIGS. 9-12 includes a body 202 and a cap 203. Thebody 202 includes an outer sleeve 204 and an inner sleeve 206 as well asa needle sleeve 207. The needle sleeve 207 is configured for axialtranslation within, and with respect to, the inner sleeve 206. The innersleeve 206 is configured for axial translation within, and with respectto, the outer sleeve 204. As shown in FIG. 10, the syringe 208 isinserted into the body 202 such that the needle 212 of the syringeextends from the distal end of the inner sleeve 206. After the syringe208 is placed within the body 202, the outer sleeve 204 can be closed.

In this embodiment, the barrel 210 of the syringe is in a fixed positionwith respect to the inner sleeve 206. A flange 210 a of the barrel 210can be positioned within a slot 240 of the inner sleeve 206 to retainthe barrel 210 in position. The flange 210 a can be integrally formedwith the barrel 210 or, alternatively, can be a separate component thatis secured to the barrel 210 by bonding or other procedure. In certainembodiments, the inner sleeve 206 includes more than one slot, each slotcorresponding to a different dose volume. For example, one slot cancorrespond to a dose volume of 0.3 mg and a second slot can correspondto a dose volume of 0.15 mg. In such an embodiment, the slots are atdifferent distances from the proximal end of the outer sleeve 204, whichleads to the delivery of differing dose volumes. With the flange 210 adisposed in the slot 240, the needle 212 extends at least partially fromthe distal end of the inner sleeve 206. This allows the cap 203 toengage the needle cover 213.

As shown in FIG. 11, the cap 203 includes features for engaging theneedle cover 213 of the syringe 208. In one embodiment, the cap 203 is aclamshell design with a living hinge 242 connecting an upper portion 244and a lower portion 246. The lower portion 246 includes a projection 248and the upper portion 244 includes an inner wall 250. During assembly,the cap 203 is closed around the needle cover 213 and connected to thebody 202. As the cap 203 is closed, the projection 248 and the innerwall 250 engage the needle cover 213. As a result, upon removal of thecap 203 from the body 202, the needle cover 213 is removed from thesyringe 208, as shown in FIG. 12.

As the cap 203 is removed from the injector 200, the needle sleeve 207translates in the distal direction relative to the inner sleeve 206.This may be caused by contact between the needle cover 213 and theneedle sleeve 207. For example, a flange 213 a (shown in FIG. 10) of theneedle cover 213 may contact the needle sleeve 207 and pull the needlesleeve 207 out as the needle cover 213 is removed. As a result, theneedle sleeve 207 covers the needle 212 and prevents inadvertent needlestick injuries. The needle sleeve 207 can provide a visual indicator,such as a contrasting color, to alert the user that the injector has notyet been used and that a needle is contained therein.

During insertion, the needle sleeve 207 is able to translate in theproximal direction with respect to the inner sleeve 206 to expose theneedle 212 for insertion into the target. Continued force applied to theouter sleeve 204 causes injection of the medicament as described above.

Upon completion of the injection, the needle 212 of the syringe 208retracts into the barrel 210 of the syringe 208. This embodiment doesnot require a biasing member to cause translation of the inner sleeve206 in the distal direction with respect to the outer sleeve 204 afterinjection. Because the needle 212 is safely enclosed in the barrel,needle stick injuries are prevented and the needle 212 is not viewableby the user. The injector 200 is compact after use and occupies lessspace when discarded, as shown in FIG. 13. Optionally, the syringe 208can be removed from the injector 200 and discarded in a sharpscontainer. In certain embodiments, the injector 200 can then be reusedfor later injections with another syringe.

In another embodiment, as shown in FIGS. 14A-14E, an spray nozzle 300 isprovided. The spray nozzle 300 can be attached to the injector 100 orthe injector 200. The spray nozzle 300 includes a body 302 and a tip 304disposed at the distal end of the body 302. The spray nozzle 300 canalso include one or more finger flanges 306, which may be located at theproximal end of the body 302. The tip 304 includes one or more holes 308at its distal end through which the medicament can exit.

The spray nozzle 300 allows for the medicament to be deliveredintranasally, which avoids the need for an insertion of a needle intothe patient, which may be preferable for some patients, specificallythose with a fear of needles. By delivering the medicament across themucosal membrane, and to the patient's blood stream, the injector withspray nozzle 300 delivers an effective dose of delivery. This can beparticularly useful for medicaments used to treat opioid overdoses, suchas Naloxone.

The spray nozzle 300 engages with the injector such that the needle isdisposed in the distal end of the spray nozzle 300. Upon distribution ofthe medicament through the needle by translating the outer sleeverelative to the inner sleeve, the medicament is compressed into a spraythat can be delivered to the patient. By providing the spray nozzle 300,the medicament can be delivered either via the spray nozzle to themucosal membranes or, alternatively, via the needle intramuscularly,subcutaneously, or at any other appropriate depth. This provides theuser or patient with the an option at time of delivery, allowing them tochoose the method of delivery which is more comfortable or effective forthem. In certain embodiments, the spray nozzle 300 and injector 100 orinjector 200 are provided in a kit, for example in a common package.

In use, cap 103 is first removed from the body 102 of the injector 100or 200. The spray nozzle 300 is placed on the body 102 such that theinner sleeve 106 or 206 abuts the distal end of the body 302 of thespray nozzle 300, as best shown in FIG. 14D. The distal end of the innersleeve 106, 206 contacts a shoulder 310 within the spray nozzle 300. Thetip 304 of the spray nozzle 300 is placed adjacent to, or at leastpartially within the nostril of the patient. A force is then applied tothe outer sleeve 104 or 204 to cause it to axially translate withrespect to the inner sleeve 106 or 206 and spray nozzle 300. Thistranslation first causes the syringe 108 or 208 to translate to aposition in which the needle 112 or 212 is at least partially within thetip 304 of the spray nozzle 300. Further translation of the outer sleeve104 or 204 causes distribution of the medicament, as described above andas shown in FIG. 14C. When operating the injector, the user may hold thefinger flanges 306 of the spray nozzle 300 to provide a counterforce.

In one embodiment, as shown in FIGS. 14D and 14E, a septum 312 isdisposed within the tip 304 of the spray nozzle 300. In someembodiments, the septum 312 maintains the sterility of the inside of thetip 304 prior to use. Depression of the outer sleeve 104 with respect tothe inner sleeve 106 causes the needle 112 to extend out of the innersleeve 106 and pierce the septum 312. The septum 312 can be constructedof a material comprising an elastomer, a silicone, or any otherappropriate material. Upon further translation of the outer sleeve 104,204 toward the tip 304, the medicament is expelled. The septum 312prevents the medicament from traveling in the proximal direction out ofthe tip 304. As a result, the contents of the syringe are expelledthrough the one or more holes 308.

In another embodiment, as shown in FIG. 15, an injector 400 is providedin which the inner sleeve 106 has a luer connector 402 at its distalend. In other aspects, the injector can be substantially the same as theinjector 100, described above. This allows the injector 400 to beconnected to a tubing set 404 to allow the medicament to be deliveredby, for example, an intravenous or intraosseous infusion device. Theluer connector 402 can be a male luer connector for connection to afemale luer fitment 406 of the tubing set. Alternatively, the luerconnector 402 can be a female luer connector for connection to a maleluer fitment. The injector 400 can be attached to the tubing set 404using locking or slipping type Luer connections, such as those soldunder the names LUER-LOK™ and LUER-SLIP™ by Becton Dickinson.

In operation, the cap 103 is removed from the body 102 of the injector400. The luer fitment 406 is then attached to the luer connector 402.The medicament can then be delivered through the tubing set 404 bytranslating the outer sleeve 104 relative to the inner sleeve 106. Thiscauses the medicament to be delivered through the luer connection, thetubing set 404, and to the patient.

As shown in FIG. 16, a grip 500 can be provided on the injector 100,200, 400. The grip 500 can for example, be integrally formed on theouter sleeve 104, 204 or, alternatively, the grip 500 can be a separatecomponent, such as a sleeve which is slid over the outer sleeve 104,204. The grip 500 can be of any size. For example, the grip 500 cancover the entire outer sleeve 104, 204. Alternatively, the grip 500 cancover only a portion of the outer sleeve 104, 204. The grip 500 can beformed from any appropriate material. For example, the grip 500 can bemolded from santoprene or other elastomeric material. The material canbe chosen to increase the ability to handle the injector 100, 200, 400.The grip 500 can include a texture or pattern to further increase theability to handle the injector 100, 200, 400. For example, the grip 500can include raised diamonds or lines, similar to that used on diamondplate.

In embodiments in which the grip 500 is a separate component that isslipped over the outer sleeve 104, 204, the grip 500 can have a closedproximal end. This can further seal the proximal end of the injector100, 200, 400 and prevent entrance of foreign particles or fluids.

A grip, such as that shown in FIG. 16, can be particularly advantageouswhen the injector is used by troops in combat situations. In thesescenarios, the injector may need to be used in harsh and damp conditionsby troops who are often wearing gloves. Hence, it may be difficult tograsp the injector securely. By providing an injector with a grip whichis easy to grasp in even difficult conditions, the injector can be usedmore reliably in these potentially life-saving scenarios.

In another embodiment, a method of operating an injector is provided.The method includes the steps of placing a distal end of an inner sleeveagainst the target location. With the injector in place, a force isapplied to an outer sleeve. Applying the force to the outer sleeve (i)causes axial translation of the outer sleeve and a syringe relative tothe inner sleeve, (ii) causes a needle of a syringe to extend out fromthe distal end of the inner sleeve and into the target location, and(iii) causes the syringe to contact an engagement member of the innersleeve. Subsequently, a continued force is applied to the outer sleeve.Applying the continued force to the outer sleeve causes translation of aplunger rod and a seal within the syringe to cause delivery of themedicament. After delivery of the medicament, the injector is removedfrom the target location. A biasing member applies a force on the innersleeve to cause the inner sleeve to translate in the distal directionwith respect to the outer sleeve to cover the needle of the syringe suchthat the inner sleeve is locked in place with respect to the outersleeve.

In another embodiment, a method of operating an injector with a syringehaving a retractable needle is provided. A cap of the injector isremoved, wherein removal of the cap also removes a needle cover of thesyringe. The method further includes the steps of placing a distal endof an inner sleeve against the target location. With the injector inplace, a force is applied to an outer sleeve. Applying the force to theouter sleeve (i) causes axial translation of the outer sleeve and asyringe relative to the inner sleeve, (ii) causes a needle of a syringeto extend out from the distal end of the inner sleeve and into thetarget location, and (iii) causes the syringe to contact an engagementmember of the inner sleeve. Subsequently, a continued force is appliedto the outer sleeve. Applying the continued force to the outer sleevecauses translation of a plunger rod and a seal within the syringe tocause delivery of the medicament. After delivery of the medicament iscomplete, the needle is retracted into the barrel of the syringe.

In another embodiment, a method of using an injector and a spray nozzleto deliver a medicament intranasally is provided. A cap of the injectoris first removed. The spray nozzle is engaged with the injector. A tipof the spray nozzle is placed within or adjacent to a nostril of thepatient. An outer sleeve of the injector is translated toward the tip ofthe spray nozzle to expel the medicament through the tip of the spraynozzle and to the patient.

In another embodiment, a method of using an injector to deliver amedicament intravenously or intraosseously is provided. A cap of theinjector is first removed. A luer connector of an inner sleeve isconnected to a luer fitment. An outer sleeve of the injector istranslated toward the luer fitment to deliver the medicament through theluer connector, through a tubing set, and to the patient.

In some embodiments, as shown in FIGS. 17A-23, a reconstitution injector600 includes a medicament container—such as a syringe or cartridge—thatincludes a lyophilized drug and a diluent. For example, injector 600 mayinclude a dual chamber syringe or cartridge such as double chambercartridges manufactured by the Schott Corporation of Elmsford, N.Y.FIGS. 17A-17H illustrate the steps of operation of the injector 600. Asshown in these figures and described in detail herein, prior toinjection, the injector 600 is used to reconstitute the medicament bymixing the lyophilized medicament with the diluent.

As shown in FIG. 17A, the injector 600 includes a first sleeve 604, asecond sleeve 606, a medicament container 608, a biasing member 617, alocking tab 650, and a pull tab 652. As described above with respect tothe embodiment shown in FIG. 1, the second sleeve 606 extends from thefirst sleeve 604 and is configured for axial translation with respect tothe first sleeve 604. In various embodiments, the first sleeve 604includes one or more raised curbs and the second sleeve 606 includes oneor more flex arms configured to engage the raised curbs and guidetranslation of the sleeves as described above with reference to FIGS.2-8C. In various embodiments, the second sleeve 606 is biased by biasingmember 617 to extend from the first sleeve 604, as described above withreference to FIGS. 2-8C. As a result, the second sleeve automaticallyextends to cover the needle of the medicament container 608 when theinjector 600 is removed from the target site, also as described above.

The medicament container 608 is disposed at least partially in the firstsleeve 604 and/or the second sleeve 606. One example of a medicamentcontainer 608 is shown in FIG. 17A. The medicament container 608includes a barrel 610, a needle 612 mounted to a distal end of thebarrel 610, a first seal 614 a, a second seal 614 b, a plunger rod 616,a shuttle 662, and a needle seal 664. In various embodiments, theplunger 616 includes a plunger head 666.

As shown in the detail view of FIG. 20, the barrel includes a main body610 a, a flange 610 b, and a neck 610 c between the main body 610 a andthe flange 610 b. The neck has an outer diameter that is less than theouter diameters of the main body 610 a and the flange 610 b. As will bedescribed further below, the locking tab 650 may be disposed between themain body 610 a and the flange 610 b to restrict translation of thebarrel 610 with respect to first sleeve 604 and/or second sleeve 606.The needle seal 664 is disposed in the barrel 610 proximate to theflange 610 b to seal the barrel 610.

Returning to FIG. 17A, the barrel 610 and seals 614 a, 614 b define afirst chamber 668 and a second chamber 670 with the second seal 614 bisolating the two chambers 668, 670. A lyophilized medicament 672 iscontained in the first chamber 668 and a diluent 674 is contained in thesecond chamber 670. As shown best in FIG. 21, the barrel 610 includes abypass 676. As will be described in more detail below, during use,depression of the plunger rod 616 causes the second seal 614 b totranslate toward the distal end of the barrel 610 until it is alignedwith the bypass 676. With the second seal 614 b in that position,continued depression of the plunger rod 616 causes the second seal 614 bto move toward the first seal 614 a, thereby causing diluent to flowthrough the bypass 676 and from the second chamber 670 to the firstchamber 668 where the diluent 674 mixes with the lyophilized medicament672 to reconstitute the medicament so that it is ready for injection.

In various embodiments, as shown in FIG. 17A, the needle 612 of themedicament container 608 is mounted to the shuttle 662. The shuttle 662is translatably engaged with the barrel 610. For example, the shuttle662 may be engaged with the flange 610 b of the barrel 610. The needle612 is positioned such that a proximal end 612 a of the needle 612extends from the shuttle 662 and toward the barrel 610 while the distalend 612 b of the needle extends from the shuttle 662 in the oppositedirection for insertion into a target site. As will be described furtherbelow, as the barrel 610 moves forward with respect to the second sleeve606 during use, the shuttle 662 contacts engagement members 635 ofsecond sleeve 606 to prevent further movement of the shuttle 662. Thiscauses the proximal end 612 a of the needle 612 to pierce the needleseal 664 to allow for the flow of the reconstituted medicament throughthe needle 612. In various embodiments, as described herein, the lockingtab 650 initially restricts motion of the shuttle 662 to preventinadvertent piercing of the needle seal 664.

One embodiment of locking tab 650 and pull tab 652 are shown in FIGS.19A and 19B. In some embodiments, the pull tab 652 is coupled to thelocking tab 650. For example, the locking tab 650 may be bonded to thepull tab 652. As shown in FIG. 18, when in place on injector 600, thepull tab 652 covers a distal aperture 654 (shown in FIG. 17A) of thesecond sleeve 606. Thus, the pull tab 652 prevents materials fromentering the inside of first and second sleeves 604, 606. The pull tab652, therefore, aids in maintaining the sterility or aseptic conditionof the needle 612. For example, the pull tab 652 prevents contaminantsfrom entering the interior of the second sleeve 606 so that suchcontaminants do not come in contact with the needle 612. The first andsecond sleeves 604, 606 may establish a tortuous path from otherpotential contaminant entry points such that even after the injector 600is removed from its sealed packaging, the aseptic nature of the needle612 is maintained for a limited amount of time. This may providesignificant advantages when the injector 600 is used in uncontrolledenvironments.

In some embodiments, pull tab 652 is constructed at least partially of amaterial that allows the needle 612 to be sterilized with the medicamentcontainer 608 disposed in the injector 600 and the pull tab 652 inplace. For example, the needle 612 may be sterilized using ethyleneoxide (EtO) sterilization. The pull tab 652 may be constructed offlashspun high-density polyethylene fibers, such as TYVEK® supplied byDuPont de Nemours, Inc. of Wilmington, Del. In some embodiments, thepull tab 652 includes an adhesive backing to secure the pull tab 652 tothe second sleeve 606. The adhesive may cover a portion or all of thepull tab 652.

The locking tab 650 is affixed to the pull tab 652 and is constructed ofa relatively rigid material, such as, for example, ABS, nylon, or otherappropriate material. As shown in FIG. 19A, the locking tab 650 mayinclude a recess 656 configured to conform to and engage a portion ofthe medicament container 608, as described further herein. Although theillustrated embodiments show the locking tab 650 coupled to the pull tab652, in other embodiments, the locking tab 650 is a separate component.

The pull tab 652 includes a covering portion 658 configured to bepositioned over the distal aperture 654 of the second sleeve 606 and anextension 660 that extends from the covering portion 658 and is coupledto the locking tab 650. As shown in FIG. 17A and FIG. 18, when the pulltab 652 is positioned on the injector 600, the covering portion 658covers the distal aperture 654 and the extension 660 extends proximallyfrom the distal end 634 of the second sleeve 606. The second sleeve 606may include a slot along the exterior of the second sleeve 606 withinwhich the extension 660 is disposed. This configuration may assist withthe alignment and placement of the pull tab 652. As shown in FIG. 17A,the locking tab 650 is initially positioned such that it prevents axialtranslation of the second sleeve 606 with respect to the first sleeve604 and, as will be described below, translation of medicament container608 with respect to the first and second sleeves 604, 606.

In a storage configuration, as shown in FIG. 17A and in detail in FIG.20, the locking tab 650 extends through an aperture 678 in the firstsleeve 604 and is in contact with or adjacent to a portion of themedicament container 608 such that the locking tab 650 restrictslongitudinal translation of the medicament container with respect to thefirst sleeve 604. For example, the locking tab 650 may be in contactwith the distal end of the barrel 610. In some embodiments, the lockingtab 650 is disposed between the flange 610 b and main body 610 a of thebarrel 610 with the recess 656 conforming to the neck 610 c. In otherembodiments, locking tab 650 contacts other portions of barrel 610 torestrict translation of the barrel 610. In some embodiments, the lockingtab 650 additionally, or alternatively, extends through an aperture 680in the second sleeve 606 to prevent translation of the second sleeve 606with respect to the first sleeve 604. In some embodiments, the lockingtab 650 may further prevent inadvertent piercing of the needle seal 664by the needle 612. For example, in embodiments in which locking tab 650is positioned between the body 610 a and flange 610 b of the barrel 610,the locking tab 650 may restrict translation of the shuttle 662 toprevent full penetration of the needle seal 664 by the needle 612. Thisensures that medicament does not flow through the needle 612 prior toactivation by the user.

Because the locking tab 650 prevents translation of the barrel 610,depression of the plunger rod 616 causes the first and second seals 614a, 614 b to translate in the distal direction with respect to the barrel610 until the second seal 614 b is aligned with the bypass 676, as shownin FIG. 17B (and in detail in FIG. 21). Continued translation of theplunger rod 616 causes the diluent to pass around the second seal 614 band through the bypass 676 and into the first chamber 668. The plungerrod 616 is depressed until the second seal 614 b is in contact with thefirst seal 614 a, as shown in FIG. 17C, such that all of the diluent hasentered the first chamber 668.

In some embodiments, with the first and second seals 614 a, 614 b incontact, the plunger rod 616 engages the first sleeve 604 to restrictfurther relative translation of the plunger rod 616 with respect to thefirst sleeve 604 such that they translate as a unit for the remainder ofthe operation of the injector 600. For example, as shown in FIG. 22, inone embodiment, the first sleeve 604 includes a groove 682 at itsproximal end. The groove 682 is configured to engage the plunger head666 of the plunger rod 616 to lock the plunger rod 616 in place withrespect to the first sleeve 604. In some embodiments, the plunger head666 includes a lip 683 to engage the locking groove 682.

With the diluent in the first chamber 668, the user can shake, swirl,tap, or otherwise facilitate mixing of the diluent and lyophilizedmedicament to ensure full reconstitution of the medicament. In someembodiments, the first sleeve 604 includes a window 684 (shown in FIG.23) that allows the user to see the first chamber 668 to verify that themedicament is reconstituted.

After the medicament is reconstituted, the locking tab 650 may berepositioned to a second position in which it does not restricttranslation of the barrel 610 with respect to the first sleeve 604. Invarious embodiment, the locking tab 650 is removed from the injector 600using the pull tab 652. For example, the pull tab 652 can be removedfrom the distal end of the second sleeve as illustrated by arrow 686 inFIG. 17C. In other embodiments, the locking tab 650 remains coupled tothe injector 600 but is slid radially outward or is rotated away fromthe barrel 610 such that the barrel 610 may translate with respect tothe first sleeve 604. FIG. 17D shows the injector after removal of thepull tab 652 and locking tab 650.

As shown in FIGS. 17E-17H, after reconstitution of the medicament andremoval of the pull tab 652 and locking tab 650, the injector 600 can beused to inject the reconstituted medicament substantially in the mannerdescribed above with respect to FIGS. 5A-8C. As shown in FIG. 17E, thedistal end of the second sleeve 606 is placed against a target site. Theplunger 616 and first sleeve 604 are then depressed to translate themedicament container 608 in the distal direction, as can be seen in thetransition from FIG. 17E to FIG. 17F. In some embodiments, the injector600 is configured such that not all of the medicament is injected. Forexample, the mixed volume of the diluent and lyophilized substance maybe approximately 1 mL and the injector 600 may be configured to inject0.5 mL. This may allow the amount of injected medicament to be closelycontrolled. In various embodiments, the amount of injected medicamentmay be controlled (e.g., between 0.15 mL and 0.5 mL) duringmanufacturing of the injector 600 by adjusting the length of the raisedcurb, as described above.

Referring to FIG. 17F, when the shuttle 662 comes into contact withengagement members 635 of the second sleeve 606 further translation ofthe shuttle 662 is restricted. Hence, continued depression of theplunger 616 and the first sleeve 604 in the distal direction causes theproximal end 612 a of the needle 612 to pierce the needle seal 664 toallow the passage of fluids from the barrel 610 through the needle 612and to the target site.

As shown in FIG. 17G, continued depression of the plunger 616 and firstsleeve 604 causes delivery of the reconstituted medicament to the targetsite. As shown in FIG. 17H, after delivery of the medicament, theinjector 600 can be removed from the target site and the second sleeve606 extends in response to a force applied by biasing member 617, asdescribed above with respect to FIGS. 8A-8B. The second sleeve 606 islocked in this position to prevent subsequent exposure of the needle612, thereby reducing the risk of needle stick injuries. After removalof the injector 600 from the target site and extension of the secondsleeve 606, the first seal 614 a and/or second seal 614 b are viewablethrough window 684, as shown in FIG. 23, to allow the user to verifythat all medicament has been delivered.

It should be understood that the reconstitution injector 600 describedabove can be used in conjunction with the spray nozzle 300 shown inFIGS. 14A-14E and described above. The reconstitution injector 600 canalso be configured to interface with the luer connector 406 as shown inFIG. 15 and described above. For example, the needle 612 and shuttle 662can be replaced with a luer connector. In addition, the reconstitutioninjector 600 can include a grip such as that shown in FIG. 16 anddescribed above.

In another embodiment, a method of injecting a medicament includesproviding an injector 600 as described herein. The method furtherincludes depressing the plunger rod 616 of the medicament container 608to mix the diluent 674 with the lyophilized medicament 672. The methodfurther includes disengaging the locking tab 650 from the medicamentcontainer 608. The method further includes placing the distal end of thesecond sleeve 606 against a target site. The method further includesdepressing the plunger rod 616 to deliver the mixed diluent andlyophilized substance.

While the foregoing description and drawings represent preferred orexemplary embodiments of the present invention, it will be understoodthat various additions, modifications and substitutions may be madetherein without departing from the spirit and scope and range ofequivalents of the accompanying claims. In particular, it will be clearto those skilled in the art that the present invention may be embodiedin other forms, structures, arrangements, proportions, sizes, and withother elements, materials, and components, without departing from thespirit or essential characteristics thereof. In addition, numerousvariations in the methods/processes described herein may be made withoutdeparting from the spirit of the invention. One skilled in the art willfurther appreciate that the invention may be used with manymodifications of structure, arrangement, proportions, sizes, materials,and components and otherwise, used in the practice of the invention,which are particularly adapted to specific environments and operativerequirements without departing from the principles of the presentinvention. The presently disclosed embodiments are therefore to beconsidered in all respects as illustrative and not restrictive, thescope of the invention being defined by the appended claims andequivalents thereof, and not limited to the foregoing description orembodiments. Rather, the appended claims should be construed broadly, toinclude other variants and embodiments of the invention, which may bemade by those skilled in the art without departing from the scope andrange of equivalents of the invention. All patents and published patentapplications identified herein are incorporated herein by reference intheir entireties.

I claim:
 1. An injector for delivering medicament comprising: a firstsleeve defining a longitudinal axis; a medicament container at leastpartially disposed within the first sleeve and configured for axialtranslation with respect to the first sleeve along the longitudinalaxis, the medicament container including a barrel, a needle mounted to adistal end of the barrel, a seal slidably mounted in the barrel, and aplunger rod; and a locking tab extending through an aperture in thefirst sleeve and in contact with or adjacent to a portion of themedicament container such that the locking tab restricts translation ofthe barrel with respect to the first sleeve along the longitudinal axis;wherein the locking tab is configured to be movable to a second positionin which the locking tab does not restrict translation of the barrel,wherein the barrel includes a main body, a flange, and a neck betweenthe main body and the flange, wherein the neck has a diameter that isless than the diameters of the main body and the flange, and wherein thelocking tab is disposed between the main body and the flange.
 2. Theinjector of claim 1, further comprising a second sleeve extending fromthe first sleeve such that the second sleeve is configured to translatewith respect to the first sleeve along the longitudinal axis.
 3. Theinjector of claim 2, wherein the locking tab restricts translation ofthe second sleeve with respect to the first sleeve along thelongitudinal axis.
 4. The injector of claim 2, wherein the locking tabis coupled to a pull tab that covers a distal aperture of the secondsleeve.
 5. The injector of claim 4, wherein the pull tab is constructedof high-density polyethylene fibers.
 6. An injector for deliveringmedicament comprising: a first sleeve defining a longitudinal axis; asecond sleeve extending from the first sleeve such that the secondsleeve is configured to translate with respect to the first sleeve alongthe longitudinal axis; a medicament container at least partiallydisposed within the first sleeve and configured for axial translationwith respect to the first sleeve along the longitudinal axis, themedicament container including a barrel, a needle mounted to a distalend of the barrel, a seal slidably mounted in the barrel, and a plungerrod; a locking tab restricting translation of the barrel with respect tothe first sleeve along the longitudinal axis; and a pull tab covering adistal aperture of the second sleeve; wherein the locking tab is coupledto the pull tab such that the locking tab is removable using the pulltab.
 7. The injector of claim 6, wherein the locking tab restrictstranslation of the second sleeve with respect to the first sleeve alongthe longitudinal axis.
 8. The injector of claim 6, wherein the pull tabis constructed of high-density polyethylene fibers.
 9. The injector ofclaim 6, wherein the plunger rod includes a plunger head and the firstsleeve includes a locking ring, and wherein the locking ring isconfigured to engage the plunger head to restrict translation of theplunger rod with respect to the second sleeve.
 10. The injector of claim6, wherein the seal divides a first chamber and a second chamber withinthe barrel, the first chamber including a lyophilized substance and thesecond chamber including a diluent.
 11. The injector of claim 6, whereinthe barrel includes a main body, a flange, and a neck between the mainbody and the flange, wherein the neck has a diameter that is less thanthe diameters of the main body and the flange, and wherein the lockingtab is disposed between the main body and the flange.
 12. A method ofinjecting medicament, the method comprising: providing an injector, theinjector comprising: a first sleeve defining a longitudinal axis; amedicament container at least partially disposed within the first sleeveand configured for axial translation with respect to the first sleevealong the longitudinal axis, the medicament container including abarrel, a needle mounted to a distal end of the barrel, a seal slidablymounted in the barrel, and a plunger rod; and a locking tab restrictingtranslation of the barrel with respect to the first sleeve; depressingthe plunger rod of the medicament container to mix a diluent with alyophilized substance within the barrel of the medicament container;disengaging the locking tab from the medicament container; placing adistal end of the injector against a target site; and depressing theplunger rod to deliver the mixed diluent and lyophilized substance. 13.The method of claim 12, further comprising removing a pull tab from thedistal end of the injector.
 14. The method of claim 12, whereindisengaging the locking tab includes removing the locking tab from anaperture extending through the first sleeve.
 15. The method of claim 12,further comprising engaging a plunger head of the plunger rod with alocking ring of the first sleeve such that, after engagement, theplunger rod and the first sleeve translate as a unit.
 16. The method ofclaim 12, further comprising piercing a needle seal disposed in thebarrel with the needle such that fluid within the barrel is able to flowthrough the needle.
 17. An injector for delivering medicamentcomprising: a first sleeve defining a longitudinal axis; a medicamentcontainer at least partially disposed within the first sleeve andconfigured for axial translation with respect to the first sleeve alongthe longitudinal axis, the medicament container including a barrel, aneedle mounted to a distal end of the barrel, a seal slidably mounted inthe barrel, and a plunger rod; and a locking tab extending through anaperture in the first sleeve and in contact with or adjacent to aportion of the medicament container such that the locking tab restrictstranslation of the barrel with respect to the first sleeve along thelongitudinal axis; wherein the locking tab is configured to be movableto a second position in which the locking tab does not restricttranslation of the barrel, and wherein the plunger rod includes aplunger head and the first sleeve includes a locking groove, and whereinthe locking groove is configured to engage the plunger head to restricttranslation of the plunger rod with respect to the first sleeve.
 18. Aninjector for delivering medicament comprising: a first sleeve defining alongitudinal axis; a medicament container at least partially disposedwithin the first sleeve and configured for axial translation withrespect to the first sleeve along the longitudinal axis, the medicamentcontainer including a barrel, a needle mounted to a distal end of thebarrel, a seal slidably mounted in the barrel, and a plunger rod; and alocking tab extending through an aperture in the first sleeve and incontact with or adjacent to a portion of the medicament container suchthat the locking tab restricts translation of the barrel with respect tothe first sleeve along the longitudinal axis; wherein the locking tab isconfigured to be movable to a second position in which the locking tabdoes not restrict translation of the barrel, and wherein the sealdivides a first chamber and a second chamber within the barrel, thefirst chamber including a lyophilized substance and the second chamberincluding a diluent.
 19. An injector for delivering medicamentcomprising: a first sleeve defining a longitudinal axis; a medicamentcontainer at least partially disposed within the first sleeve andconfigured for axial translation with respect to the first sleeve alongthe longitudinal axis, the medicament container including a barrel, aneedle mounted to a distal end of the barrel, a seal slidably mounted inthe barrel, and a plunger rod; and a locking tab extending through anaperture in the first sleeve and in contact with or adjacent to aportion of the medicament container such that the locking tab restrictstranslation of the barrel with respect to the first sleeve along thelongitudinal axis; wherein the locking tab is configured to be movableto a second position in which the locking tab does not restricttranslation of the barrel, and wherein the medicament container furthercomprises: a shuttle fixedly coupled to the needle and translatablycoupled to the barrel; and a needle seal disposed in the barrel,wherein, during operation, the needle and shuttle translate with respectto the barrel and the needle pierces the needle seal to allow fluids topass from the barrel to the needle.